FDA warns against Atlantic Pharmacy sterile products

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., doing business as Atlantic Pharmacy and Compounding, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Read the FDA safety alert.